CEFTRIAXONE NEONATAL THERAPY (CEFSINT) : A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA

Withdrawn

• Conditions: hyperbilirubinaemia; jaundice; 10019654

• Registration Number: NL-OMON37438
• Lead Sponsor: Sint Elisabeth Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

Neonates (0-28 days of age), presenting to the participating hospitals (EZ, TSZ) with serious bacterial infection requiring systemic antibiotic therapy.

Exclusion Criteria

Gestational age < 34 weeks; severe congenital malformations; erythrocyte transfusion; blood group antagonism or other types of antibody antagonism; haemoglobinopathy; malignancy; serious perinatal asphyxia, concomitant use of intravenous calcium containing solutions (due to the risk of fatal calcium-CFT precipitations in blood vessels).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The incidence of hyperbilirubinemia in neonates in both groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The incidence of pseudolithiasis of the biliary and urogenital tract and other<br /><br>known adverse reactions between neonates in both groups. </p><br>